Z-0121-2019Class II

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

Name: Z-0121-2019 CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Creator: CryoLife, Inc.
Published: 2018-09-06
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2018-09-06 / Terminated / root cause: labeling and UDI

FDA source

CryoLife, Inc. began a recall of CryoPatch SG Pulmonary Hemi-Artery, 1 graft on 2018-09-06. FDA classified it as Class II and gives the reason as "The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0121-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-06
Posted: 2018-10-18
Terminated: 2020-03-03
Recalling firm: Artivion, Inc.
Product: CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: A formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation.
Quantity in commerce: 1 graft
Distribution: US Nationwide in the state of California.
Product codes and lots: Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0121-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-17

Product code DXZ

K091626Class IICryopatch Sg Pulmonary Hemi-Artery; Trunk; BranchCryolife, Inc. / cleared 2009-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)